Tag: FDA

As published on Huffington Post’s new LGBT Wellness blog, see original at: http://www.huffingtonpost.com/scout-phd/e-cigarettes-friend-or-foe_b_5024583.html

Working in tobacco control sometimes elicits interesting reactions from people. Some try to hide their smoking. While I certainly appreciate not being near the smoke itself, I’ve got great empathy for smokers. In fact, since most smokers have already tried to quit, they’re much more likely to be fellow fighters against tobacco than non-smokers. Sometimes they ask me how to best quit and I’m happy to tell them (hint, call 1-800-QUITNOW). These days everyone’s asking me something new: What about e-cigarettes? The shortest answer is “they could be helpful for a few, but we all worry about our youth.”

First, if you’re not familiar with e-cigs, they are battery-powered imitators of old-school cigarettes, designed to deliver nicotine, flavor and other chemicals through vapor inhaled by the user. Most of them have a swag little electronic light at the tip to make it seem more like an old-school cig. Some now have other names like e-hookah to avoid any cigarette associations. The claim is here’s a no-combustion device to get your nicotine fix, great for cessation and great to smoke in places where cigarettes are banned.

There is one study supporting the effects of e-cigs in helping people quit smoking but now another study is out contravening it. Considering how toxic cigarette smoke is, we all applaud anything that helps reduce the amount of cigarette smoke in the air. But if you’re trying to use e-cigs as a cessation device it’s a bit dicey right now because they’re unregulated, so the amount of nicotine you get in each dose varies, and sometimes does not match the advertising. It’s commonly known that it only takes about two weeks to kick the nicotine addiction of smoking, but anyone who’s quit will tell you, it’s the social habit of smoking that draws you back again and again. I’m not sure how putting a cigarette replacement in your mouth helps you kick that social habit — sounds to me like it’s just perpetuating it. Plus there is a new study showing other toxic chemicals in the vapor. To top it off, there’s no real science on the long-term effects of inhaling nicotine vapor. So while I’m willing to bet it’s better than inhaling tobacco smoke, that’s like saying I bet it’s better than inhaling truck exhaust. Nicotine is so toxic, poison control centers just issued an alert about high numbers of calls on accidental exposure. Just touching the liquid is enough to cause vomiting and ingesting as little as a teaspoon of some of the liquid nicotine concentrations can be fatal. I hope people set a higher bar for their own cessation journey.

The real problem is, as anyone who’s visited a vaporium can see, it’s not a cessation game. Vaporiums and e-cigs are all about enticing, and particularly enticing young people. Wander into your local vaporium belly up to the “bar” and you’ll be shocked to see how many vaporiums look like the lovechild of a hip coffee shop and a candy store. I’m not sure exactly which adult Marlboro user would switch to cotton candy flavored nicotine cartridges, or banana nut bread, or cherry limeade. Sounds to me more like flavors I’d find at a little league game. To make it worse, these products are easily available online and many states aren’t yet doing anything to restrict access to minors. Data show LGBT youth continue to smoke at rates much higher than their non-LGBT counterparts and the number of youth experimenting with e-cigs is rising rapidly… the very last thing we need is to have some fancy new gadgetry on the market enticing LGBT youth to start using a highly addictive drug to deal with the stress of stigma against us all.

We pass on smoking down through the LGBT generations socially. I’ve always called it an STD for us, a socially transmitted disease. So I also worry about adult e-cig use. Every time you “light up” you’re perpetuating the huge LGBT cigarette culture, all of us laughing and having fun and hanging out, with cigarettes in our mouths.

We already have cessation aids that deliver you nicotine in controlled regulated doses, you can find those on every drugstore shelf. Nicely, there’s not one gummy bear or watermelon flavored nicotine patch, spray or gum. So while e-cigs might help a few in quitting, I say the big picture on e-cigs for the LGBT communities is we need to think of our youth and “beware of the wolf in sheep’s clothing.”

For five years now we’ve been charged with pointing out gaps and best practices in the LGBT tobacco arena. Since aspects of the LGBT tobacco disparity overlap almost every health issue, funding, cultural competency, research, and of course data, this means we’ve been monitoring gaps in a wide range of areas. As more of all of our work has shifted to the policy level changes, we’ve increasingly focused on assisting in developing stronger policy responses to help advance our field. Well, we think it’s time to review some of the range of policy change documents we’ve created to make sure you have them at your fingertips to use locally. (Especially since our old resource library makes them a bit hard to find! Don’t worry the new one is almost finished.)

As a grassroots network a large amount of our documents are created by and then reviewed by the Network base. Frankly, we’d like to think we’ve got good foresight and dreamed up the idea of most of these the the truth is very different. Almost all of these documents were created because you, or some state, or federal official asked for them. So, if you need something, do like Bill Snook from Missouri just did, call us and ask if we have it, or if we can make it!

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Our friends at the Asian Pacific Partners for Empowerment, Advocacy and Leadership

(APPEAL) had another recent great success with organizing a petitioned letter to the Congressional Asian Pacific American Caucus (CAPAC) requesting they ask FDA to remove menthol.

With a great number of signatures (including the Network’s), CAPAC did write a letter to FDA not only asking that menthol be removed but providing recommendations on further reducing tobacco use in diverse communities. You can see the letter here: CAPAC Menthol Letter. Now, we will wait and see if FDA moves on menthol.

This is a great show of collaboration led by APPEAL, and we congratulate their successful efforts!

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The FDA is making an effort to have a substantive ‘dialogue’ involving a spectrum of interests. This would be a great opportunity for LGBT folks to attend and join the dialogue to represent our communities’ needs. If you’re in the area, let us know if you’re planning to attend.

Blanke shares that for the most part, state, cities and counties have led tobacco control efforts despite federal acts. For federal policies to take place, states and cities need to be active in enforcing federal policies and enhancing current policies. So what can be done?

6 Roles of States and Cities

A Force Multiplier – states will enforce federal laws by compliance checks, as ears to the grounds to understand applicability

Voice of Experience – wrestling with tobacco industry hasn’t always been pretty for states, but states have the first-hand experience of means to do this work

Accountability – states/cities hold the tobacco industry accountable on the grassroots level and have to defend against the opposition

Partners in policy – states and cities have more jurisdiction and power in certain ways to act that FDA does not. For instance, states and cities can add more bans and more warning labels than federally required.

Experimentation – states and cities can experiment with new policies and counter-marketing when the federal government doesn’t have that same leeway.

Hold the most powerful tools – States have the most powerful levers to achieving tobacco elimination visions

Though there are many steps that Blanke suggests for states and cities, he stresses that in many ways the FDA needs states and cities more than they need the FDA. So don’t be thinking the role of states and cities will be overshadowed by FDA announcements and acts or that it wasn’t the work of states and cities that got us here!

Joseph P. Kennedy III (grandson of Robert Kennedy), nephew of Ted Kennedy has a career of public health service and advocacy and spoke to the legacy of the Kennedy’s in tobacco control. At today’s event, he was presented with the honoring of Senator Edward Moore Kennedy’s great contribution to tobacco control adding to the family legacy as seen below.

Kennedy Tobacco Control Timeline

1962 – Surgeon General Warning announced by JFK.

1967 – Robert Kennedy gave address to World Conference on Tobacco or Health

Now in 2011 FDA has broadened authority to restrict tobacco marketing. Hopefully just as it has done for food labeling, regulating meat and dairy, responding quickly to approve HIV medications, great strides will be made in our protection from tobacco in short order.

As this conference memorialized the great work of late Senator Ted Kennedy and legacy of the family in the past 50 years, Joseph Kennedy talks about how this fight goes back even further, and is owed largely to other activists and scientists who shoveled against the tide of society’s widespread acceptance of tobacco.

Joseph acknowledges the losses within the century and complacancy of all areas of society and the government. Cigarettes were defended by doctors, given out in airplanes and sponsored basketball games. To folks like Joseph and myself, that is unbelievable.

Kennedy recognizes the scientists and activists who led this cause. These wins were made by us and our predecessors. As a result of the struggles and successes, for Joseph and my generation, smoking is not allowed in as many public spaces, it’s universally seen as unhealthy and just isn’t as cool anymore. We have generations of advocates, and some of you reading this, to thank!

Dr. Phillip Gardinier of Nicotine Dependence & Policy Research at the University of California presented on the “FDA Involvement of Stakeholders in the Regulatory Process: Still Time to Remedy the Situation.”

He spoke about the communities that are left out of the tobacco control movement, policies, research and debate on tobacco control, and the need to reach out to those left out. We of course know that those left out are low-SES people, communities of color and us (the LGBT communities) which we applaud Dr. Gardinier for clearly pointing out.

For example since NAATPN and communities of color weren’t included in policy discussions of the Family Smoking Prevention and Tobacco Control Act, menthol was not restricted in that Act.

The question here is if all stakeholders are equal? And the answer is no since tobacco representatives are invited to the table more than disparity groups despite their history of lies and deceit and violation of laws.

So what needs to be done?

We need an Office of Health Disparities – To ensure voices are always heard and better position against tobacco industry and coordinate with the Office of Minority Health. CTP is to be applauded for reaching out to the most affected groups. Most importantly, communities experiences tobacco disparities and traditionally left out of the conversation, should be included. If the tobacco industry is brought up, but not minority groups, they win as they are still selling their products to minority groups.

As a result of this presentation, it’s ever more clear that we’re fortunate to be here as the LGBT Network and happy to represent our communities and report this important information and collaborations to all of you.

Dr. Gary Giovino, University of Buffalo, presented on Tobacco Use in American in the Last Decade (2000-2010). There is more tobacco use of non-traditional forms. For instance cigar use is going up with pipes and snuff. (Everything but chewing tobacco, but I mean, gross…not surprised!) Even though cigarette prevalence has gone down, smokeless tobacco is leveled. This is true for youth with rates level that don’t adjust down with cigarette prevalence. Additionally, menthol tobacco use is continuing its rate.

There are concerns with flavored products, deceptive and regulated advertisements of smokeless tobacco are real future considerations. These attract youth, getting youth hooked and contributing to the cycle of tobacco use, because its youth that the tobacco industry relies on to continue its lethal work.

This is why it’s so important to keep track of trends of tobacco industry, but understand they are not hard to follow as the same tired tactics continue: deception and marketing to youth.

Tobacco use has been on a steady decline of about 2% each year since the early 1990s. While this has shown large decrease over a generation, the reduction is still very gradual and is starting to plateau. However new FDA regulation and authority with Affordable Care Act provisions, we hope to see a drop in smoking prevalence.

This decline has occurred, as a result of the Kennedy legacy with decades of restrictive national tobacco laws and tobacco control advocacy. Chief Counsel for Policy for Sen. Ted Kennedy, Jeffrey Teitz commented on the passion of Sen. Kennedy on extinguishing the threat of tobacco. Part of the reason for this passion was his priorities to protect children and provide for the health of the American people, which are passions shared by many of us which propel us into this advocacy. Hence it’s clear that this is a memorial conference to the late Senator.

A recent mechanism, and Ted Kennedy’s last tremendous success, was the passage of the Affordable Care Act, signed into law in 2009 as you likely know. This law gave FDA the regulatory and legal tools to fight tobacco for public health. This law breaks down into three main restrictions against the tobacco industry.

Combating tobacco industry efforts to encourage children to smoke and deceiving.

When too much oppositional media attention exposes a marketing trend, the tobacco industry shifts to another campaign. Now the FDA has the authority to combat this, ahead of the trend, for prevention rather than reacting after each campaign.

Regulate manufacturing of tobacco

Cigarettes are more than tobacco wrapped in paper as they contain 1000s of chemicals to make their products more addictive (and also lethal), but FDA will require an ingredient list and set performance standards of product composition.

Preventing claims that certain projects are healthier

FDA requires new tobacco products with “safer” claims to submit their products to review. Most claims of “low tar” and “mild” were disproved, so it’s unlikely new products will meet FDA standards and thus be unable to advertise in this way. The tobacco industry will do what it can to drain resources of FDA but submitted numerous claims. Big Tobacco has already started this strategy and given their decades of exhausting plaintiff claims with endless appeals and resources invested in defensive litigation.

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As you may know, the LGBT Tobacco Control Network and other public health advocates have anticipated these new federal regulations on tobacco control!

A message from the CDC’s Office on Smoking and Health:

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are working together to educate consumers, public health partners, and the general public about new tobacco regulations that take effect today, June 22, 2010. These regulations limit the sale, distribution, and marketing of cigarettes and smokeless tobacco to individuals younger than 18 years of age; require larger and stronger health warning labels to appear on smokeless tobacco advertisements and on smokeless tobacco products manufactured on or after June 22, 2010; and prohibit the tobacco industry from manufacturing for sale or distribution any tobacco products for which the label, labeling, or advertising contains the descriptors “light,” “low,” or “mild” (or any similar descriptor).

CDC and FDA are seeking your support to help get the word out about these new, historic FDA tobacco regulations. You can support this effort by

· Posting a “Put Out the Myth” graphical button on your Web site. When clicked, this button will take visitors to a consumer-focused feature article on CDC’s Web site (www.cdc.gov/features/tobaccocontrols) entitled “New Tobacco Controls Have Public Health Impact.” This article provides information on the regulations and their public health impact. The article also contains helpful links to resources—such as FDA guidance documents—that provide detailed information on the new regulations. Visit the “Put Out the Myth” download page at http://www.cdc.gov/tobacco/stateandcommunity/fda_regs/buttons/index.htm to obtain html code for a variety of button sizes.

· Following OSH on GovLoop at www.govloop.com/group/CDCTobaccoFree. A post on GovLoop announces the significance of June 22 and encourages readers to visit the online feature article. GovLoop is a social networking site for the government community. It currently serves about 30,000 members, including local, state, and federal government employees and contractors. Academics and students interested in government are also welcome to join.

· Subscribing to CDC’s Smoking and Tobacco Use Main Feed at www.cdc.gov/tobacco/rss/index.htm to receive updates of new and recently changed content from CDC’s Smoking & Tobacco Use Web site on your browser or desktop.